Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
1 other identifier
interventional
449
1 country
27
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2007
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
March 5, 2013
CompletedMarch 5, 2013
January 1, 2013
1.7 years
May 15, 2007
March 26, 2010
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
One month after infant series dose (at 5 months of age)
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units \[IU\]/mL) and Tetanus (0.01 or 0.1 \[IU\]/mL).
One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Secondary Outcomes (1)
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
One month after toddler dose (at 16 months of age)
Other Outcomes (2)
Percentage of Participants Reporting Pre-Specified Local Reactions
During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
During the 4-day period after each dose
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy 2-month-old infants
- Available for the entire study period
You may not qualify if:
- Previous vaccination with any vaccine before the start of the study
- Known contraindication to vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
A Coruña, 15270, Spain
Unknown Facility
A Coruña, 15405, Spain
Unknown Facility
Almería, 4007, Spain
Unknown Facility
Almería, 4009, Spain
Unknown Facility
Almería, 4120, Spain
Unknown Facility
Barcelona, 8195, Spain
Unknown Facility
Barcelona, 8930, Spain
Unknown Facility
Madrid, 28041, Spain
Unknown Facility
Madrid, 28900, Spain
Unknown Facility
Madrid, 28922, Spain
Unknown Facility
Madrid, 28942, Spain
Unknown Facility
Málaga, 29015, Spain
Unknown Facility
Málaga, 29200, Spain
Unknown Facility
Ourense, 32005, Spain
Unknown Facility
Pamplona, 31008, Spain
Unknown Facility
Santiago de Compostela, 15706, Spain
Unknown Facility
Seville, 41013, Spain
Unknown Facility
Valencia, 46008, Spain
Unknown Facility
Valencia, 46011, Spain
Unknown Facility
Valencia, 46021, Spain
Unknown Facility
Valencia, 46022, Spain
Unknown Facility
Valencia, 46023, Spain
Unknown Facility
Valencia, 46024, Spain
Unknown Facility
Valencia, 46183, Spain
Unknown Facility
Valencia, 46200, Spain
Unknown Facility
Valencia, 46930, Spain
Unknown Facility
Vigo, 36204, Spain
Related Publications (1)
Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
PMID: 23965217DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Spain: infomed@wyeth.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2007
First Posted
May 17, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 5, 2013
Results First Posted
March 5, 2013
Record last verified: 2013-01